Improving Clinical Trial Cycle Times through Increased Partnership

1
Improving Clinical Trial Cycle Times through
Increased Partnership
Nancy Trapp Clinical Operations Team
Leader-Regulatory, Eli Lilly and Company

• Current State
• In general, the pharmaceutical industry aims for
  the cycle time between site selection to the time
  a site is deemed ready to enroll a patient to
  take 90 days for private/independent sites and
  120 days for academic sites.
• Eli Lilly and Company (Lilly) is currently
  performing at an average of approximately 125
  days for academic sites becoming regulatory
  ready.
• Therefore, improving the regulatory readiness
  timelines of academic sites that participate in
  clinical research trials may decrease the time it
  takes to make important clinical options
  available to patients.

Johns Hopkins/Lilly Six Sigma Potential Root
Causes for Delayed Cycle Times
Johns Hopkins/Lilly Six Sigma Tips and Tricks

• Establish single point of contact (sponsor and
  academic institution)
• Understand each others processes and required
  internal reviews (process, timing, requirements)
  and expectations
• Complete a Template / Master Letter of
  Confidentiality
• Master Letter of Agreement
• Standard template for non-protocol pieces of ICD
  and usual procedure language
• Site budget out of Lilly within 5 days and
  accompanied by protocol
• Continued technological advancements and IT
  solutions
• Consistent and frequent communications and status
  updates

• Lack of communication about where the study is in
  the process (at academic site and with the
  sponsor)
• Lots of wait time within and between steps
• Unclear contact person academic site and/or
  sponsor
• Lack of process definitions and lack of knowledge
  about process
• Lack of access to information
• Lots of hand-offs

Johns Hopkins/Lilly Six Sigma Improvements

• Improved Communication
• Lilly CRA will communicate to JH-CRO and JH-ORA
  when PI is contacted and signs Confidentiality
  Agreement Developed Communication Template to
  use throughout the process
• Partner JH with Lilly-Budget Office and
  Lilly-Contract Office to resolve template issues
  and overhead
• Agreed on use of .pdf files and signatures in any
  order on study amendments to Master Service
  Agreement
• Improve the CRC Process / Tracking System
• Lilly Investigator Portal Goes live
  throughout 2008
• JH CRMS Goes live July 1, 2008 and will have
  many features including a dashboard
• Help for the PI
• Dashboard in CRMS
• Standard Confidentiality Agreement
• Standard Master Service Agreement
• Standard Informed Consent
• Standard costs for Pharmacy, SAC Lab, and
  Professional fees

Cycle Times
Academic Institution Metrics Cycle Time of CTRB
Shipment Date to ICD Approval Date (median number
of days)
Academic Institution Metrics Cycle Time of Site
Selection Date to LOA Approval Date (median
number of days)
Sponsor Mike Amey, JH/Chris Davis, LLY Project
4279 Black Belt Kathy Ann Lawrence
Country USA
Case Study Johns Hopkins/Lilly Six Sigma
Oncology
Improving Regulatory Readiness Timelines

• Problem
• Multiple review boards and serial process steps
  lead to lengthy site readiness activities when
  partnering with academic research centers.  
• Johns Hopkins/Lilly has median values for Site
  Readiness (CTRB shipped to CT ordered) at 169
  days. 
• Goal
• Our goal is to reduce variability and cycle
  times within the site readiness process for Johns
  Hopkins research sites by 15 (24 days).

• Root Causes
• Lack of communication about where the study is in
  the process
• Lots of wait time within and between steps
• Unclear contact person at Johns Hopkins and/or
  Lilly
• Solutions
• Improved communication tools
• Improve Clinical Review Committee process and
  tracking tools at Johns Hopkins
• Help for the Primary Investigator and Johns
  Hopkins staff

Green Quick WinGrey Improvement with
Simulation Black Future Benefit
Confirm120 The Process Flow Map
Data on file at Eli Lilly and Company
Data on file at Eli Lilly and Company
Academic Institution Metrics Cycle Time of CTRB
Shipment to Regulatory Ready Date (median number
of days)

• Project Approach
• Champions, sponsors, and team members from Johns
  Hopkins and Lilly.
• Two-day face-to-face meetings in Measure,
  Analyze, and Improve Six Sigma sessions at
  alternating facilities.
• Openness and trust in the partnership to put it
  all on the table for discussion and improvement.
• Internal communication within each partner and
  external via publication.

• Expected Results
• A 37 reduction in regulatory readiness cycle
  time (from a median of 169 days to 107 days).

• Validation
• Lilly to provide list of trials in Oncology and
  other therapeutic areas.
• Johns Hopkins will also measure other sponsor
  improvements in Oncology.

Pilot and Quick Win Goals
Potential Solution Identification
Data on file at Eli Lilly and Company
In 3 hours, the Johns Hopkins / Lilly team
Academic Institution Metrics Percentage of Sites
Declared Regulatory Ready by Date of Planned FPV
Control ChartAcademic Institutions Control Chart
of CTRB Ship to Reg Ready

• Brainstormed 69 different possible ideas
• Grouped the 69 ideas into 5 categories
• Developed 13 possible improvements
• Prioritized and combined the 13 possible
  improvements into 4 solutions with teams to work
  on them.

Improving the regulatory readiness timelines of
academic sites that participate in clinical
research trials may decrease the time it takes to
make important clinical options available to
patients.
Data on file at Eli Lilly and Company
Data on file at Eli Lilly and Company
CTSA Clinical Research Management Workshop